Artelo Taps Worldwide for Phase 1 ART26.12 Trial

Artelo Biosciences, a pharmaceutical company specializing in the development of treatments for cancer, pain, and neurological conditions, has announced its collaboration with Worldwide Clinical Trials, a renowned contract research organization (CRO). The partnership is aimed at supporting Artelo's upcoming Phase 1 trial of ART26.12, a Fatty Acid Binding Protein 5 (FABP5) inhibitor designed to treat chemotherapy-induced peripheral neuropathy (CIPN).

Gregory D. Gorgas, President and CEO of Artelo Biosciences, expressed excitement about the collaboration, highlighting Worldwide's expertise in neurology and its track record in assisting companies with clinical trials. He believes that ART26.12's promising results in animal models of painful neuropathies will pave the way for successful human studies.

Peter Benton, President and CEO of Worldwide Clinical Trials, shared his enthusiasm for the partnership, emphasizing the potential of ART26.12 as a non-opioid pain drug. He looks forward to supporting Artelo in evaluating the safety of their FABP5 inhibitor.

The global neuropathic pain market is a significant one, estimated to be worth $7.6 billion by Coherent Market Insights. This underscores the urgent need for innovative therapies that can offer relief to patients with limited treatment options. Artelo has conducted five pre-clinical studies on painful neuropathies, including diabetic neuropathy and CIPN, which currently lacks FDA-approved treatments. The company has reported a positive pre-IND meeting with the FDA and is expected to file the IND for ART26.12 in the first half of this year.

FABPs are a family of intracellular proteins that play a crucial role in lipid signaling, which is implicated in various pathologies. ART26.12 is a potent and selective FABP5 inhibitor being developed as a novel analgesic for CIPN. Artelo's library of small molecule FABP inhibitors has shown therapeutic potential for treating cancers, neuropathic and nociceptive pain, and anxiety disorders.

Worldwide Clinical Trials is a leading global CRO that partners with biotech and pharmaceutical companies to advance new medications. Their services include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval studies. With a focus on neuroscience, oncology, rare diseases, and cardiometabolic and inflammatory diseases, Worldwide operates in nearly 60 countries with over 3,400 team members.

Artelo Biosciences is dedicated to developing and commercializing therapeutics that modulate lipid-signaling pathways, including the endocannabinoid system. The company is advancing a portfolio of product candidates designed to address significant unmet needs in various diseases and conditions, such as anorexia, cancer, anxiety, pain, and inflammation. Artelo is led by experienced biopharmaceutical executives who collaborate with respected researchers and technology experts to develop high-impact therapies.

CIPN is a type of neuropathic pain caused by chemotherapy and other cancer treatments. It poses a significant challenge for oncological treatments, potentially leading to reduced doses or treatment cessation, which can negatively affect treatment efficacy and patient survival. Acute CIPN occurs during chemotherapy, while chronic CIPN can persist for months to years after treatment, with approximately 30% of patients still experiencing symptoms a year or more after completing chemotherapy.